Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker

The aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with pacemaker compared with their healthy peers.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Pacemaker
• Intervention / Treatment: Other: Physical activity and physical fitness assessment

Detailed Description

Studies in children with heart diseases suggest that physical activity levels are reduced relative to their peers, which in turn increases cardiovascular risk factors and cardiac rhythm problems. To the best of our knowledge, physical fitness and objectively measured physical activity levels of children with a pacemaker have not been studied. The aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with a pacemaker compared with their healthy peers.

Investigators enrolled clinically stable pediatric patients and used the echocardiogram to evaluate cardiac functions of all patients. Physical fitness was assessed using the Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic Holter device was used to record the physical activity level for consecutive 7 days.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit and Hacettepe University Faculty of Medicine, Department of Pediatrics, Department of Pediatric Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with pacemakers who were followed routinely in Hacettepe Hospital, Department of Pediatric Cardiology.

Description

Inclusion Criteria:

Inclusion criteria of the Pacemaker Group:

• Permanent pacemaker
• Being 7-18 years of age
• Able and willing to complete the informed consent process
• Able to walk and co-operate

Exclusion Criteria:

Exclusion criteria of Pacemaker Group:

• Unstable medical condition
• To have severe neurological, severe orthopedic problems
• To have severe heart failure and another systemic disease or acute infection
• Down Syndrome
• The control group will consist of healthy subjects.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control	Other: Physical activity and physical fitness assessment; Physical fitness was assessed using Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic holter device was used to record the physical activity level for consecutive 7 days. The functional exercise capacity of the individuals was assessed by the six-minute walking test (6MWT) and cardiorespiratory capacity was assessed by maximal exercise test on the treadmill.
Pacemaker	Other: Physical activity and physical fitness assessment; Physical fitness was assessed using Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic holter device was used to record the physical activity level for consecutive 7 days. The functional exercise capacity of the individuals was assessed by the six-minute walking test (6MWT) and cardiorespiratory capacity was assessed by maximal exercise test on the treadmill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level	Physical activity index will be measured using activity monitor for seven consecutive days.	seven days
Total Number of Steps	Participants will wear an accelerometer (physical activity monitor) for seven consecutive days.	seven days
Munich Physical Fitness Test Score	The test consists of six different parameters, including balancing and bouncing (speed and coordination), accurate throw (speed and coordination), trunk flexibility, vertical jumping (power), hanging (endurance and strength), and step test (endurance, speed and coordination). After all the parameters are completed, the score of each parameter is calculated from the standardization chart according to age and sex. This total score is divided by the number of parameters and recorded as Munich total score. Physical fitness is classified according to scores as deficient (<35), normal (36-45), satisfactory (46-55), good (56-65) and very good (>66).	1st day (before using device)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercise capacity (6 minutes walk test)	6-minute walk test will be performed in a long, straight, enclosed corridor 30 meters in length. Patients are required to walk in their walking speed with standardized instructions. The distance walked by subjects during 6 minutes will be recorded.	1st day (before using device)
Cardiorespiratory Capacity (maximal exercise test on the treadmill)	The symptom limited maximal exercise test will be performed without gas exchange measurement. The Modified Bruce Protocol will be applied on the treadmill.	8th day (last day of the assessment)

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2017
• Primary Completion (Actual): May 25, 2018
• Study Completion (Actual): June 24, 2018

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; pediatric; pacemaker; physical fitness
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: GO 17/880

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No